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G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181134
510(k) Type
Traditional
Applicant
Sunstar Americas Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2018
Days to Decision
74 days
Submission Type
Summary

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181134
510(k) Type
Traditional
Applicant
Sunstar Americas Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2018
Days to Decision
74 days
Submission Type
Summary